Sr. Manager, Design Quality Engineering - Product Compliance

DexCom • San Diego, CA

11d • Remote

About The Position

Dexcom is seeking a senior Design Quality Engineering leader to own electrical safety, electromagnetic compatibility (EMC), and radio certification compliance across the product lifecycle. The role establishes global compliance strategies for IEC 60601 requirements across the continuous glucose monitoring product portfolio, leads worldwide radio certification and market-access activities for wireless medical devices, and governs surveillance of external standards and assessment of their impact on products and quality systems.

The position provides quality engineering leadership across development, commercialization, sustaining engineering, post-market monitoring, and product change management. It works closely with Regulatory Affairs, R&D, Clinical, Manufacturing, and external certification agencies to proactively address compliance risks, resolve escalations, and support business objectives. The role is the Quality function decision maker for assigned platforms and represents the organization in regulatory audits and inquiries.

The successful candidate will lead, organize, develop, and grow an organization of Compliance Engineers while ensuring project teams receive the required quality engineering support. The primary work location is a home office, with no assigned workstation; the employee must live within commuting distance of the assigned Dexcom site, typically 75 miles or 120 km. Travel is 15–25%.

Requirements

• Bachelor’s degree in a technical discipline; a Bachelor’s degree in Engineering is preferred.
• Typically requires 13 or more years of industry experience.
• Requires 5–8 years of previous people-management experience.
• Demonstrated leadership experience working with NRTLs on medical-device certification strategies and with local regulatory authorities globally to obtain radio certifications.
• Ability to adapt to shifting priorities and manage multiple initiatives.
• Exceptional interpersonal, written, and verbal communication skills.
• Self-motivated, collaborative, proactive, and accountable approach.

Nice To Haves

• Bachelor’s degree in Engineering.

Responsibilities

• Own the global compliance strategy for IEC 60601 electrical safety and EMC standards across the CGM product portfolio.
• Ensure compliance requirements are effectively integrated throughout the product lifecycle.
• Engage with Nationally Recognized Testing Laboratories (NRTLs) on certification strategies and provide on-site testing support.
• Lead worldwide radio certification and market-access activities for wireless medical devices, including approvals and ongoing compliance across global markets.
• Establish and govern external standards surveillance and impact-assessment processes, translating evolving requirements into product and quality-system plans.
• Provide quality engineering leadership for lifecycle compliance across development, commercialization, sustaining engineering, post-market monitoring, and product change management.
• Drive cross-functional alignment with Regulatory Affairs, R&D, Clinical, Manufacturing, and external certification agencies to manage compliance risks and support business objectives.
• Resolve escalations, guide teams toward solutions, and act as the Quality function decision maker for assigned platforms.
• Build positive, supportive, and collaborative partnerships with cross-functional peers and leaders.
• Lead, organize, develop, and grow an organization of Compliance Engineers and ensure project teams receive appropriate quality engineering support.
• Represent the organization during regulatory audits and inquiries.

Benefits

• Full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Career development through in-house learning programs and/or qualified tuition reimbursement.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior